PreDiabetesNCT05572749
Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents
A study testing Crocus Kozanis and Metformin in people with PreDiabetes and Obesity, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The study aims to investigate possible effects of per os Crocus Kozanis administration in children and adolescents with obesity Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- PreDiabetes, Obesity, Dyslipidemias
- What is being tested?
- Crocus Kozanis and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age above 10 year-old
- Diagnosis of Obesity according to International Obesity Task Force Criteria
- Presence of impaired glucose tolerance and/or impaired fasting glucose
Who cannot join
- Overt diabetes (any type)
- Diagnosis of any chronic disease
- Previous use of dietary supplement with Crocus or Crocus Sativus
- Administration of chronic medication
Trial locations and contacts
1 site in 1 country.
Greece1 site
Unit of Paediatric Endocrinology and Metabolism, 2nd Department of Paediatrics, AHEPA University Hospital
Thessaloniki
About this study
Official title: Double-blind Randomized Cross-over Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents
The study aims to investigate possible effects of per os Crocus Kozanis administration in children and adolescents with obesity
- Conditions
- PreDiabetes, Obesity, Dyslipidemias
- Being tested
- Crocus Kozanis, Placebo of Crocus Kozanis, Metformin
- Medical subject headings
- Prediabetic State, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crocus KozanisDietary supplement
Also called Saffron, Crocus Sativus, Saffron Kozanis
In this study, intervention will be the administration of Crocus Kozanis dietary supplement. Crocus Kozanis is a herb which is cultivated in Kozani, Greece.
Placebo of Crocus KozanisDietary supplement
Placebo of Crocus Kozanis
MetforminDrug
Also called Metformin Hydrochloride
Metformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants of Arm 1 are going to be administered Crocus Kozanis for 12 weeks (30mg twice per day), wash-out period for 12 weeks and metformin (1000mg once per day) for 12 weeks. Receives: Dietary Supplement: Crocus Kozanis; Drug: Metformin |
| Arm 2 | Experimental | Participants of Arm 2 are going to be administered metformin (1000mg once per day) for 12 weeks, wash-out period for 12 weeks and Crocus Kozanis (30mg twice per day) for 12 weeks. Receives: Dietary Supplement: Crocus Kozanis; Drug: Metformin |
| Arm 3 | Placebo comparator | Participants of Arm 3 are going to be administered placebo (5ml twice per day) for 12 weeks Receives: Dietary Supplement: Placebo of Crocus Kozanis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Glycemic control will be assessed with glycated hemoglobin (ΗbA1c%) and/or oral glucose tolerance test (OGTT)
Measured: Glycemic control will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).
Secondary outcomes (1)
Lipidemic profile
Lipidemic profile will be assessed with levels of cholesterol, triglycerides, HDL and LDL in fasting state
Measured: Lipidemic profile will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 May 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki
- Investigators
- Assimina Galli-Tsinopoulou, Professor, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572749
- Sponsor's protocol ID
- Crocus Kozanis & Child Obesity
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Cross-over Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents
- ClinicalTrials.gov ID
- NCT05572749
- Acronym / sponsor ID
- Crocus Kozanis & Child Obesity
- Conditions
- PreDiabetes, Obesity, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate possible effects of per os Crocus Kozanis administration in children and adolescents with obesity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Dietary Supplement: Crocus Kozanis, Drug: MetforminParticipants of Arm 1 are going to be administered Crocus Kozanis for 12 weeks (30mg twice per day), wash-out period for 12 weeks and metformin (1000mg once per day) for 12 weeks. |
| Arm 2 | Experimental | Dietary Supplement: Crocus Kozanis, Drug: MetforminParticipants of Arm 2 are going to be administered metformin (1000mg once per day) for 12 weeks, wash-out period for 12 weeks and Crocus Kozanis (30mg twice per day) for 12 weeks. |
| Arm 3 | Placebo comparator | Dietary Supplement: Placebo of Crocus KozanisParticipants of Arm 3 are going to be administered placebo (5ml twice per day) for 12 weeks |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age above 10 year-old
- Diagnosis of Obesity according to International Obesity Task Force Criteria
- Presence of impaired glucose tolerance and/or impaired fasting glucose
Key exclusion criteria (4 listed)
- Overt diabetes (any type)
- Diagnosis of any chronic disease
- Previous use of dietary supplement with Crocus or Crocus Sativus
- Administration of chronic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crocus KozanisAlso: Saffron, Crocus Sativus, Saffron KozanisIn this study, intervention will be the administration of Crocus Kozanis dietary supplement. Crocus Kozanis is a herb which is cultivated in Kozani, Greece. | Dietary supplement | Arm 1, Arm 2 |
| Placebo of Crocus KozanisPlacebo of Crocus Kozanis | Dietary supplement | Arm 3 |
| MetforminAlso: Metformin HydrochlorideMetformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe. | Drug | Arm 1, Arm 2 |
Primary outcome
Glycemic control
Time frame: Glycemic control will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).
Glycemic control will be assessed with glycated hemoglobin (ΗbA1c%) and/or oral glucose tolerance test (OGTT)
1 secondary outcome
Lipidemic profile
Time frame: Lipidemic profile will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assimina Galli-Tsinopoulou, Professor study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crocus Kozanis and Metformin in people with PreDiabetes and Obesity, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: Glycemic control will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.